Radiotherapy Dose Escalation in Locally Advanced Squamous Cell Carcinoma of the Larynx or Hypopharynx

NCT ID: NCT03388931

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-04
• Study Completion Date: 2019-05-06

Brief Summary

This is a phase 2 single arm study of a novel schedule of hyperfractionated radiotherapy (RT) in combination with our standard chemotherapy program for patients with stage 3-4 squamous cell carcinoma of the larynx. The primary hypothesis of our study is that the study program will improve Laryngectomy-Free Survival compared to historical controls. The study is limited to patients who would be receiving primary RT-C as standard therapy off-study.

Detailed Description

The novel radiotherapy schedule that is the subject of this study is only slightly different from the program that has been used in the cooperative group trial RTOG 9003. The radiation therapy dose schedule in our study twice-daily alternating fractions over 30 treatment days. The Biologically Effective Dose (BED) of this schedule is about 11% higher than our standard schedule twice-a-day. During radiotherapy, patients will receive chemotherapy with our standard program of weekly.

Conditions

Advanced Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Increased dose of radiation therapy for locally advanced squamous cell carcinoma of the larynx or hypopharynx. Patients will also receive standard-of-care chemotherapy with the treatment regimen to be determined by the treating physicians.

Group Type: EXPERIMENTAL

Radiation Therapy

Intervention Type: RADIATION

Increased radiation therapy dose

Chemotherapy

Intervention Type: COMBINATION_PRODUCT

Standard-of-care chemotherapy with treatment regimen to be determined by the treating physician

Interventions

Radiation Therapy

Increased radiation therapy dose

Intervention Type: RADIATION

Chemotherapy

Standard-of-care chemotherapy with treatment regimen to be determined by the treating physician

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age (no upper age limit)
• Biopsy proven squamous cell carcinoma of the glottis or supraglottic larynx or hypopharynx with the following T,N and M stages:
• Glottic Larynx:

T3-4: Any primary tumor volume

• Supraglottic Larynx:

T2: Primary tumor volume > 4.0cc T3-4: Any primary tumor volume

• Hypopharynx:

T2: Primary tumor volume > 4.0cc T3-4: Any primary tumor volume

• N-Stages (the same for all primary sites): All N-stages
• M-Stages (the same for all primary sites): M0 or M1suitable for curative attempt with Stereotactic Body Radiation Therapy.
• Radiologic evaluation of the chest within 12 weeks prior to treatment; at a minimum, chest x-ray is required. CT imaging of the chest or PET/CT is acceptable.
• ECOG Performance Status 0-2
• CBC/differential obtained within 8 weeks prior to treatment, with adequate bone marrow function defined as follows:
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
• Adequate renal and hepatic function within 4 weeks prior to treatment, defined as follows:
• Serum creatinine < 2.0 mg/dl
• Total bilirubin < 2 x the institutional ULN
• AST or ALT < 3 x the institutional ULN.

*Note that physician attestation of patient having no known history of liver disease can take the place of bilirubin and AST/ALT labs.

• Negative pregnancy test within 2 weeks prior to treatment for women of childbearing potential
• Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
• Patients must be deemed able to comply with the treatment plan and follow-up schedule.
• Patients must provide study specific informed consent prior to study entry

Exclusion Criteria

• Prior history of radiation therapy to the head and neck that would likely increase the risk of serious complications from the RT delivered on this protocol
• Prior history of head and neck cancer with the exception of nonmelanoma skin cancer.
• Currently taking Disease Modifying Rheumatoid Drugs (DMRDs)
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol.
• Pre-existing ≥ grade 2 neuropathy
• Prior organ transplant
• Systemic lupus
• Psoriatic arthritis.
• Known HIV positive. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Amdur, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

OCR17025

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201702707

Identifier Type: -

Identifier Source: org_study_id